Effect of Music Intervention on Intravitreal Injection

Sponsor
Afyonkarahisar Health Sciences University (Other)
Overall Status
Completed
CT.gov ID
NCT04212338
Collaborator
(none)
219
1
3
2.4
90.1

Study Details

Study Description

Brief Summary

The objective of this study was to examine the effect of music intervention in the before-intravitreal injection (IVTI) and during-IVTI periods on patients' anxiety, the sensation of pain, physiological variables, satisfaction, and surgeon-patient cooperation. The study used a randomized controlled experimental design. The study was conducted with a total of three groups: two experimental (Before-IVTI (Group1) and During-IVTI music intervention group (Group 2)) and one control group. Each of the experimental and control groups consisted of 75 patients. The patients' anxiety was evaluated using the VAS anxiety scale, pain using the VAS pain scale; surgeon-patient cooperation using the Numeric Rating Scale; and patient satisfaction with a 5-point likert-type satisfaction scale.

Condition or Disease Intervention/Treatment Phase
  • Other: Before intravitreal injection music intervention
  • Other: during intravitreal injection music intervention
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
219 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Supportive Care
Official Title:
Effect of Music Intervention on Pain, Anxiety, Physiological Variables, Patient Satisfaction, and Surgeon-Patient Cooperation in Intravitreal Injection
Actual Study Start Date :
Mar 11, 2019
Actual Primary Completion Date :
May 24, 2019
Actual Study Completion Date :
May 24, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: study group 1

Before intravitreal injection music intervention: These patients received the standard treatment and listened to music for a period of 15 minutes 30 minutes before the injection.

Other: Before intravitreal injection music intervention
The patients in the Before-IVTI group listened to music for a period of 15 minutes 30 minutes before the injection.

Experimental: study group 2

During-intravitreal injection music intervention:These patients received the standard treatment and listened to music during the injection (approximately 5 minutes).

Other: during intravitreal injection music intervention
The patients in the During-IVTI group listened to music during the injection (approximately 5 minutes).

No Intervention: control group

The music intervention was not conducted with the patients in the control group. These patients received the standard treatment.

Outcome Measures

Primary Outcome Measures

  1. Visual Analog Scale for Anxiety (VAS-A) [1 day]

    VAS-A is a measurement tool, in which 0 represents feeling "no anxiety" while 10 represents "I feel extremely anxious".29 An increase in score indicates an increase in the anxiety experienced by the patient. This indicates that VAS-A is a reliable and accurate measurement tool despite its brevity. The VAS-A scale was applied to patients before, immediately after, and 15 minutes after the injection.

Secondary Outcome Measures

  1. Visual Analog Scale for Pain (VAS) [1 day]

    VAS scale is a single-dimensional scale that is commonly used to evaluate pain severity. According to the VAS, pain severity is rated from 0 (no pain) to 10 (the greatest imaginable pain). Any score under 3 on the scale is considered "mild pain", scores between 3 and 6 are "moderate pain" and any score above 6 is "severe pain". The VAS was applied both immediately after the injection and 15 minutes afterwards in order to determine the severity of the pain that the patients felt during the injection.

Other Outcome Measures

  1. Surgeon-patient cooperation [1 day]

    Numeric Rating Scale (NRS) was used. This scale allows for a score of between 0 and 10 points.A score of 0 indicates that the patient was totally noncompliant with the surgeon's instructions and a score of 10 indicates that the patient was totally compliant. The NRS was used by the surgeon for each patient immediately after the conclusion of the injection.

  2. Patient Satisfaction [1 day]

    In this study, on the basis of the review of the literature, satisfaction was evaluated using a 5-point Likert-type scale. The patients were asked to respond "Very Unsatisfied", "Unsatisfied", "Neutral", "Satisfied", or "Very Satisfied". The patients' levels of satisfaction were evaluated 15 minutes after the injection.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • The participants were patients aged 18 or above,

  • Who did not have a hearing/speech impairment, a mental problem or a diagnosed psychiatric disorder, who had not received a diagnosis of depression, who volunteered to participate in the study, and on whom elective IVTI was carried out, or who had undergone IVTI previously.

Exclusion Criteria:
  • The participants were patients aged under 18 years

  • Who had a hearing/speech impairment, a mental problem or a diagnosed psychiatric disorder, who had received a diagnosis of depression, who did not volunteered to participate in the study, and or who had not undergone IVTI previously.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Afyonkarahisar Health Science University Afyonkarahisar Centre Turkey 03200

Sponsors and Collaborators

  • Afyonkarahisar Health Sciences University

Investigators

  • Principal Investigator: Yeliz Ciğerci, +90 272 444 0304

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Yeliz Ciğerci, Director, Afyonkarahisar Health Sciences University
ClinicalTrials.gov Identifier:
NCT04212338
Other Study ID Numbers:
  • 2019/76
First Posted:
Dec 27, 2019
Last Update Posted:
Dec 27, 2019
Last Verified:
Dec 1, 2019
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Dec 27, 2019